SILK ROAD MEDICAL, INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3014526664	3007215228	SILK ROAD MEDICAL, INC.	1	Y	2020-04-25	1213 Innsbruck Drive Sunnyvale CA US 94089

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00811311020362	ENROUTE Transcarotid Stent - 5 mm X 20 mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021260	ENROUTE Transcarotid Stent - 8-6mm x 30mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021277	ENROUTE Transcarotid Stent - 8-6mm x 40mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021284	ENROUTE Transcarotid Stent - 9-7mm x 30mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021291	ENROUTE Transcarotid Stent - 9-7mm x 40mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021307	ENROUTE Transcarotid Stent - 10-8mm x 30mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021314	ENROUTE Transcarotid Stent - 10-8mm x 40mm	1-855-410-8227	customerservice@silkroadmed.com
00811311021321	ENROUTE Transcarotid Stent - 10-7mm x 40mm	1-855-410-8227	customerservice@silkroadmed.com

silkroadmed.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration key	Listing key	Premarket submission	Device	Product code	Decision date
219886	1426590073	P140026	ENROUTE TRANSCAROTID STENT SYSTEM	NIM	2015-05-18
219886	1986355887	K160643	ENROUTE 0.014 Guidewire	DQX	2016-10-18
219886	1897725112	K153485	ENROUTE Transcarotid Neuroprotection System	NTE	2016-03-10

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product code	Registration listing records	Latest decision
DQX	1	2016-10-18
NTE	1	2016-03-10
NIM	1	2015-05-18

PMN#

ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter
2022-09-02
Silk Road Medical, Inc.
ENROUTE Transcarotid Neuroprotection System
2016-03-10
SILK ROAD MEDICAL, INC.

GUDID#

ENROUTE Transcarotid Stent - 8-6mm x 30mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 8-6mm x 40mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 9-7mm x 30mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 9-7mm x 40mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 10-8mm x 30mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 10-8mm x 40mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 10-7mm x 40mm
Silk Road Medical, Inc.
2023-06-22
ENROUTE Transcarotid Stent - 5 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 5 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 5 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 6 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 6 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 6 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 7 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 7 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 7 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 8 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 8 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 8 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 9 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 9 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 9 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 10 mm X 20 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 10 mm X 30 mm
Silk Road Medical, Inc.
2016-07-28
ENROUTE Transcarotid Stent - 10 mm X 40 mm
Silk Road Medical, Inc.
2016-07-28
"ENROUTE .014"" Guidewire" - "ENROUTE .014"" Guidewire, US"
Silk Road Medical, Inc.
2017-03-30
"ENROUTE .014"" Guidewire" - "ENROUTE .014"" Guidewire, US"
Silk Road Medical, Inc.
2017-03-30
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 4.5mm X 25mm
Silk Road Medical, Inc.
2022-11-01
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 5mm X 25mm
Silk Road Medical, Inc.
2022-11-01
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 4mm X 35mm
Silk Road Medical, Inc.
2022-11-01
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 4.5mm X 35mm
Silk Road Medical, Inc.
2022-11-01
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 5mm X 35mm
Silk Road Medical, Inc.
2022-11-01
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 5.5mm X 25mm
Silk Road Medical, Inc.
2022-11-02
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 6mm X 25mm
Silk Road Medical, Inc.
2022-11-02
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 5.5mmx35mm
Silk Road Medical, Inc.
2022-11-02
ENROUTE Enflate Transcarotid RX Balloon Dilatation Catheter - 6mmx35mm
Silk Road Medical, Inc.
2022-11-02
ENROUTE Enflate Transcarotid RX Balloon Dilation Catheter - 4mm x 25mm
Silk Road Medical, Inc.
2022-10-26
ENROUTE Transcarotid Neuroprotection System - Angled-Tip Arterial Sheath Configuration
Silk Road Medical, Inc.
2016-03-14
ENROUTE Transcarotid Neuroprotection System - Straight-Tip Arterial Sheath Configuration
Silk Road Medical, Inc.
2016-03-14
ENROUTE Transcarotid Neuroprotection System - Angled-Tip Arterial Sheath Configuration
Silk Road Medical, Inc.
2017-01-25